Catalog Number

-

Brand Name

Solaris

Version/Model Number

T100A-160087

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

-

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K100077,K100077,K100077,K100077,K100077,K100077,K100077,K100077

Product Code

DQA

Product Code Name

Oximeter

Public Device Record Key

5ac36c16-dfa0-4422-bbc0-6a0f90b6bbb8

Public Version Date

November 10, 2021

Public Version Number

6

DI Record Publish Date

September 23, 2016

Package DI Number

56900234150115

Quantity per Package

80

Contains DI Package

06900234100115

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

box